Combined Lactobacilli (Reuteri LMG P-27481 and GG ATCC 53103) to Prevent Antibiotic Associated Sy… (NCT04836013) | Clinical Trial Compass
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Combined Lactobacilli (Reuteri LMG P-27481 and GG ATCC 53103) to Prevent Antibiotic Associated Symptoms in Children
Italy216 participantsStarted 2021-05-13
Plain-language summary
This is a prospective multicenter pediatric double-blind, randomized placebo-controlled, parallel group clinical trial intended to evaluate the efficacy, safety and tolerability of a combined probiotic (LGG and L. reuteri LMG P-27481) in the prevention of antibiotic associated diarrhea and gastrointestinal symptoms in hospitalised children treated with antibiotics for proven or suspected bacterial infection.
Who can participate
Age range
12 Months – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (all of the following):
* Children aged 12 months to 12 years
* Proven or suspected bacterial infection
* Inpatient children needed antibiotic treatment
* Oral or intravenous or intramuscular antibiotic administration with at least 2 days of duration
* Parental informed consent to the participation to the study
Exclusion Criteria:
* Age below 12 months or above 12 years
* Infections with no or only one day of antibiotic treatment
* Sepsis or severe generalized infection
* Pancreatitis
* Known immunodeficiency or chronic gastrointestinal diseases or heart disease
* Oncologic patients
* Severe neurological impairment or lack of verbal expression
* Enteral or parenteral nutrition
* Gastrointestinal malformations or abdominal surgical interventions
* Central line catheter
* Acute or chronic diarrhea when starting antibiotics
* Current or recent (in the last four weeks) use of any probiotic product
* Antibiotic treatment started earlier than 24 hours before enrollment
* Absence of parental consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of antibiotic-associated diarrhea, defined as episodes of otherwise unexplained diarrhea (≥3 loose or liquid stools per day with negative viral and bacterial stool tests), recorded by instructed parents in a structured daily diary.
Timeframe: From the second day after starting antibiotic treatment to 2 weeks after stopping antibiotics